enGen Track System with TCAutomation Software Version recall: Software Issue
enGen Track System with TCAutomation Software Version 4.2
Why was enGen Track System with TCAutomation Software Version recalled?
A software anomaly with TCA Software V4.2 may potentially cause a delay in reporting of results due to patient samples being routed to an unintended location when samples are reintroduced back onto the enGEN track
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial numbers: 5GV6W2J, 3RHC23J, 7KSC15J, 953252, CXL941J & JG7BFB5J Product Code 952019-EG, 952020-EG, 952055
- Product
- enGen Track System with TCAutomation Software Version 4.2
- Recalling firm
- Ortho-Clinical Diagnostics
- Quantity
- 16
- Distribution
- Domestically - GA, IL, MO, NC & NY; Internationally - Canada, England, France, Italy & Spain
- Recall date
- December 20, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)